BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OLYMPIC INFANT THERMOMETER

    K Number: K954434 · Decision Dec 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    37
    Review Days
    86

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OLYMPIC INFANT THERMOMETER
    K Number
    K954434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympic Medical Corp.
    Date Received
    September 25, 1995
    Decision Date
    December 20, 1995
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FLL), ordered by most recent decision date.

    Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Infrared Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Olympic Medical Corp.

    K Number Device Name
    K081094 OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
    K031149 OLYMPIC CFM 6000
    K020335 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
    K001056 OLYMPIC WARM-UP
    K983229 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
    K971601 OLYMPIC BILI-BASSINET
    K972193 OLYMPIX MINI-PASTEURMATIC (58210)
    K971117 WARMETTE
    K955357 OLYMPIC SMART SCALE MODEL 50/50RA
    K954846 OLYMPIC SMART SCALE
    Search all 37 clearances from Olympic Medical Corp. →